CN112370606A - Extended use medical device - Google Patents

Abstract

The present invention relates to an extended use medical device. A medical device for administering a drug treatment to a user for an extended period of use comprising: a pump mechanism for administering a drug to a user; a delivery cannula for transcutaneous infusion of the drug into a user at an infusion site; and a mechanism for controlling deployment of the cannula into the user's body, wherein the mechanism is configured to variably move the cannula to a first depth and a second depth.

Description

Extended use medical device

This application is a divisional application of the patent application having application number 201710466501.2, and the patent application having application number 201710466501.2 is a divisional application of the patent application having application number 201410069293.9. Further, the patent application No. 201410069293.9 is a divisional application of patent applications No. 201080045902.7, application date No. 9/1/2010, and invention name "medical device for extended use".

Technical Field

The present invention relates generally to wearable, self-contained drug infusion devices that provide lower cost therapy and extended life by extending the feasibility of the infusion site. In addition, the extended use drug infusion device is effective in providing continuous glucose monitoring not previously available with conventional wearable drug infusion devices. Additional embodiments provide a programmable drug delivery device for use in conjunction with the above drug infusion device for providing even further control and accuracy of drug therapy.

Background

Diabetes is a group of diseases marked by high blood glucose levels due to defects in insulin production, insulin action, or both. There are 2360 million people (or 8% of the population) in the united states who have diabetes. The total incidence of diabetes increased by 13.5% since the year 2005-2007. Diabetes can lead to serious complications and premature death, but there are well-known products available to diabetics to help control the disease and reduce the risk of complications.

Treatment options for diabetic patients include specialized diets, oral treatment, and/or insulin therapy. The main goal of diabetes treatment is to control the blood glucose (sugar) level of a patient in order to increase the chances of a non-complication life. Achieving good diabetes management while balancing other living needs and circumstances is not always easy.

Currently, there are two major modes of daily insulin therapy for the treatment of type I diabetes. The first mode includes syringes and insulin injection pens, which require a needle stick for each injection (typically three to four times per day), but are simple to use and are relatively low cost. Another therapy that is widely adopted and effective for managing diabetes is the use of conventional insulin pumps. Insulin pumps can help users keep their blood glucose levels within a target range based on their individual needs through continuous controlled infusion of insulin. By using an insulin pump, users can adapt their insulin therapy to their lifestyle instead of adapting their lifestyle to how, for example, insulin injections work on them.

Conventional insulin pumps are capable of delivering fast-acting or short-acting insulin 24 hours a day through a catheter placed subcutaneously. Insulin doses are typically administered at a basal rate and in a single dose. Basal insulin is delivered continuously over 24 hours with the goal of maintaining the individual's blood glucose levels within a consistent range between meals and during the night. Some insulin pumps are capable of programming the basal rate of insulin to vary according to different times of day and night. A bolus dose is typically administered when the user has a meal, and usually provides an additional bolus injection of insulin to balance the carbohydrate consumed. Some conventional insulin pumps allow a user to program the volume of a bolus dose according to how many or the type of meal consumed. Conventional insulin pumps also allow the user to introduce a correction or supplemental bolus of insulin to compensate for a low blood glucose level when the user calculates a bolus dose.

Conventional insulin pumps have many advantages over other insulin therapies. Insulin pumps deliver insulin over time rather than in a single injection, and thus typically result in smaller variations in the American Diabetes Association (ADA) recommended blood glucose range. The conventional insulin pump reduces the number of acupuncture times that a patient must endure and allows a user to manage diabetes more conveniently and effectively, thereby remarkably improving the quality of life of the user. Insulin pumps, however, are cumbersome to use and are typically more expensive than other therapies. From a lifestyle standpoint, conventional pumps, tubing, and infusion sets can be inconvenient and cumbersome for the user.

Recent advances in insulin therapy have provided "wearable" drug infusion devices that are less costly and more convenient and comfortable to use than conventional insulin pumps. Some of these devices are intended to be partially or completely disposable and in theory provide many of the advantages of conventional insulin pumps without the initial high cost and inconvenience of conventional insulin pumps.

Wearable medical devices capable of performing similar functions as conventional insulin pumps are becoming more and more popular, but still at higher costs. Although the initial cost of each wearable medical device is far lower than conventional insulin pumps, the cost of providing medication using wearable medical devices throughout the year is magnified due to the short duration of use of such medical devices. Common wearable medical devices are typically discarded after up to 3 days of operation. Some drivers of the duration of use of such medical devices include infusion site feasibility for extended periods of time and the challenge of reasonably providing adequate insulin supply during such extended periods of time and effectively providing a robust power source over the extended life of the device. Extending the use of wearable medical devices to last 5-7 days will greatly reduce the daily cost of therapy, thus enabling a larger population to afford the convenience provided by such therapies. Therefore, if the daily cost of such therapies is reduced, the availability of such wearable medical devices will increase.

Accordingly, there is a need in the art to extend the duration of use of wearable medical devices, thereby providing more cost effective medication so that more diabetic patients can benefit from the advantages provided by these devices.

Additionally, most wearable medical devices available in the art are typically referred to as "smart" or "simple" medical devices. "smart" skin-proximity pumps commonly used in the art typically receive instructions from and/or transmit patient data to a smart controller or host device, which requires wireless or wired communication between the pump and the controller. Due to the additional components necessary to provide communication with the host device, a "smart" skin pump is typically larger in size, heavier, and more expensive than a "simple" skin pump. In addition, typical "smart" devices require user interaction for blood glucose monitoring, single dose calculation, and dose programming, which adds complexity and risk to the intended use of these devices. On the other hand, commonly used "simple" skin patches pumps typically provide only a preset base dose. For many users, the level of complexity of "smart" devices is unacceptable, but their therapeutic needs are not met by "simple" skin-contact pumps. Therefore, there is a need to provide a specialized insulin therapy that is not available with a "simple" skin-proximity pump, but does not require the added cost and complexity of a "smart" skin-proximity pump.

Disclosure of Invention

Exemplary embodiments of the present invention address at least the above problems and/or disadvantages and provide at least the advantages described below. It is therefore an object of certain embodiments of the present invention to provide a wearable medical device that further reduces the daily cost of insulin therapy by extending the duration of use of the medical device. It is another object of certain embodiments of the present invention to provide a reprogrammable skin pump that provides specialized insulin therapy without the high costs typically associated with "smart" skin pumps.

A first aspect of the invention provides a medical device for administering a drug treatment to a user for an extended period of use. The medical device includes: a pump mechanism for administering a drug to a user; first and second delivery cannulas for transcutaneous infusion of the drug into a user at first and second infusion sites; and first and second mechanisms for separately controlling deployment of the first and second cannulas into the user's body at the first and second infusion sites. The medical device further comprises a flow sensing unit for detecting whether the first infusion site is no longer feasible by sensing whether the first delivery cannula is blocked or otherwise unable to deliver a desired flow of medication to the user, wherein the first delivery cannula is withdrawn from the user when the flow sensing unit detects that the infusion site is no longer feasible. Additionally, the first delivery cannula may be withdrawn from the user after a predetermined period of use. Deploying the second delivery cannula into the user's body upon withdrawal of the first delivery cannula, wherein the first and second mechanisms for controlling the first and second delivery cannulas are manually or automatically actuated. The medical device further comprises a reservoir for supplying a volume of medicament necessary for an extended duration of use of the medical device. The medical device may further comprise first and second reservoirs for supplying medicament to the respective first and second delivery cannulae. The medical device may further comprise a refillable reservoir for supplying a drug for infusion into the body of a user, the container comprising a port or septum for receiving the supply of drug, or may even comprise a receptacle for receiving a prefilled container assembly. Additionally, the medical device may include a reusable and a disposable portion, wherein the pump mechanism and the first and second mechanisms for controlling deployment of the first and second cannulas are housed within the reusable portion of the medical device.

A second aspect of the invention provides a medical device for administering a medication to a user for an extended period of use. The medical device includes: a pump mechanism for administering a drug to a user; a delivery cannula for transcutaneous infusion of the drug into a user at an infusion site; and a mechanism for controlling deployment of the cannula into the user's body, wherein the mechanism is configured to variably move the cannula to a first depth and a second depth for a duration of use of the medical device. The mechanism for controlling deployment of the cannula is configured to withdraw the cannula after a predetermined period of use and to further redeploy the cannula into the user's body after a predetermined period of non-use. The medical device also includes a disposable and a reusable portion, wherein the pump mechanism and the mechanism for controlling deployment of the cannula are housed in the reusable portion of the medical device.

A third aspect of the invention extends the use of a medical device comprising first and second delivery cannulas for administering a medication to a user by: the method may further comprise deploying the first cannula into a user at an infusion site for administering a drug to the user, withdrawing the first cannula from the user, and deploying the second cannula into the user at a second infusion site for administering the drug to the user. The method also determines whether the infusion site is no longer feasible by detecting that the first cannula is blocked or fails to deliver a desired flow of medication to the user, and withdraws the first cannula from the user when the infusion site is determined to be no longer feasible. The method may also withdraw the first cannula from the user after a predetermined period of use. The step of deploying further comprises deploying the respective cannula into the user's body at the respective infusion site, either automatically or manually.

A fourth aspect of the present invention extends the use of a medical device comprising a single delivery cannula for administering a drug treatment to a user by: deploying the delivery cannula into a user at an infusion site to a desired depth for administering a drug to the user, and variably moving the cannula to a second desired depth while the drug is being administered to the user. The method also determines whether flow of medication to the user is prevented and variably moves the cannula to the second desired depth when it is determined that flow of medication is prevented. The method may also include variably moving the sleeve to the second desired depth after a predetermined period of use.

A fifth aspect of the present invention extends the use of a medical device comprising a single delivery cannula for administering a drug treatment to a user by: deploying the delivery cannula at an infusion site into a user body to a desired depth for administering a drug to the user, determining that a predetermined time period has elapsed since deploying the delivery cannula, withdrawing the cannula from the user when it is determined that the predetermined time period has elapsed, and reinserting the cannula at the infusion site for re-administering the drug to the user after a second predetermined time period. The method also inserts the cannula to a second desired depth.

Another aspect of the invention provides a partially disposable and partially reusable medical device for administering a drug treatment to a user. The medical device includes a reusable housing and a disposable housing, each having at least one exposed interface for engaging with each other. The reusable housing includes: a pump mechanism for administering a drug to a user; a cannula deployment mechanism for deploying a delivery cannula for infusing the drug into a user's body; and a controller for controlling the pump mechanism and the cannula deployment mechanism. The disposable housing contains the delivery cannula and a reservoir for containing a supply of medication for infusion into the user's body. The reusable housing may also contain a sensor deployment mechanism.

A further aspect of the invention provides a drug delivery device having a programmable controller, a drug cartridge, an infusion needle and a micro-pump disposed between the infusion needle and the drug cartridge, wherein the controller is programmed by a host device which calculates a bolus dose of drug to be administered to a user through the infusion needle and programs the controller to set the dose to be administered to a user. The drug delivery device is preferably an insulin injection pen and the host device is one of a personal diabetes manager, a blood glucose monitor, a single dose calculator and a wearable drug infusion device of one of the exemplary embodiments of the present invention. The host device preferably calculates a bolus dose from at least one factor selected from the group consisting of: test strip results, body function sensor signals, basal rate infusion history, and meal information. The programmable drug delivery device preferably comprises electrical contacts for direct communication with the host device and may alternatively communicate with the host device via a private network. The programmable delivery apparatus is preferably programmed when in direct communication with the host device and also includes a rechargeable battery that is recharged when in direct contact with the host device.

A final aspect of the invention provides a wearable medical device for administering a drug treatment to a user, the wearable medical device comprising: a unitary housing containing a reservoir for containing a supply of a drug in fluid communication with an infusion cannula for delivering the drug to a user; pump mechanism means for delivering the drug from the container to a user through the infusion cannula; and a preprogrammed controller that controls the pump mechanism to provide a preprogrammed drug delivery profile to a user. The controller is preferably pre-programmed by the manufacturer of the medical device or a health care provider and may be pre-programmed to provide a specific drug infusion rate according to an electronic timer or time of day or alternatively may be pre-programmed to provide multiple daily infusions of a dose of a drug to a user.

Objects, advantages and features of the present invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the present invention.

Drawings

The above and other exemplary features and advantages of certain exemplary embodiments of this invention will become more apparent from the following description of certain exemplary embodiments of this invention when taken in conjunction with the accompanying drawings, in which:

FIG. 1A is an illustration depicting a medical device according to an exemplary embodiment of the present invention;

FIG. 1B is an illustration of an actuation mechanism for use in a medical device according to an exemplary embodiment of the present invention;

FIG. 2 is a block diagram depicting the major components of a medical device according to an embodiment of the invention;

3A-3B illustrate an exemplary infusion needle for a medical device according to an embodiment of the present invention;

3C-3E illustrate exemplary operation of a needle deployment mechanism according to an exemplary embodiment of the present invention;

fig. 4 shows a medical device according to another exemplary embodiment of the present invention;

fig. 5 shows a medical device according to another exemplary embodiment of the present invention;

6A-6F illustrate a needle deployment mechanism for use in a medical device according to an exemplary embodiment of the invention;

6G-6H illustrate additional exemplary embodiments of the needle deployment mechanism shown in FIGS. 6C-6F for any of the exemplary embodiments of a medical device;

fig. 7A shows a refillable/refillable reservoir in a medical device according to an exemplary embodiment of the present invention;

FIG. 7B illustrates an insertable/replaceable reservoir assembly of a medical device according to an exemplary embodiment of the present invention;

FIGS. 8A-8B illustrate a partially reusable/partially disposable medical device according to an exemplary embodiment of the present invention;

8C-8F illustrate placement of a needle deployment mechanism for use in a partially reusable/partially disposable medical device according to an exemplary embodiment of the present invention;

FIG. 9 is a block diagram depicting the major components of a sensing unit according to an exemplary embodiment of the present invention;

FIGS. 10A-10B are diagrams illustrating the primary operation of a continuous glucose monitoring system according to an exemplary embodiment of the present invention;

11A-11C illustrate an exemplary embodiment of an adhesive design for attaching a medical device to a user according to an exemplary embodiment of the present invention;

fig. 12A-12B illustrate additional embodiments of programmable drug delivery devices for use in conjunction with medical devices according to exemplary embodiments of the present invention.

Throughout the drawings, like reference numerals will be understood to refer to like elements, features and structures.

Detailed Description

The subject matter illustrated in this description is provided to assist in a comprehensive understanding of exemplary embodiments of the invention and is described with reference to the accompanying drawings. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the exemplary embodiments described herein can be made without departing from the scope and spirit of the present invention, which is defined by the following claims. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

A general embodiment of amedical device 100 is shown in fig. 1 and 2. Themedical device 100 is preferably a wearable medical device that provides delivery of a liquid or gel medicament, preferably but not necessarily insulin, by continuous infusion into or through the skin of a patient. Such known medical devices are commonly referred to as "skin-patch pumps" due to their nature of being worn on or attached to the skin of a user. Themedical device 100 generally includes a housing (which is shown in fig. 1 as including anupper housing portion 102 and a lower housing portion 104), a rigid orflexible drug reservoir 106 or other container for supplying a medicament, aninfusion needle mechanism 108, and apump mechanism 114 for controlling the delivery of the medicament to a user's body through an infusion needle provided in theinfusion needle mechanism 108 via aflow passage 112. Themedical device 100 also preferably includes a microprocessor orcontroller 116 for directing the infusion needle mechanism and pump mechanism as well as monitoring and/or controlling other preferred operations and systems of themedical device 100.Medical device 100 may also include anoptional flow sensor 120 and anoptional power source 109, such as any known power source, including but not limited to a standard battery, capacitor, or energy harvesting system, such as that disclosed in commonly assigned and co-pending U.S. patent application serial No. 12/458,807, filed on 7/23/2009, which is incorporated herein by reference.

One exemplary embodiment of themedical device 100 is a pre-programmed skin pump. The pre-programmed skin-proximity pump may include simple intelligence for providing a customized basal infusion rate that can be varied throughout the day to meet the sleep and awake insulin requirements. A pre-programmed skin pump may be programmed to deliver one or more drugs to a user at different rates for different times of day or under different conditions. Changing the drug delivery rate over time is referred to herein as the drug delivery profile (profile). The pre-programmed skin patch pump may be programmed by the manufacturing facility or healthcare provider and preferably does not require additional user programming. Even pre-programmed skin patches pumps may be configured to provide multiple daily infusions and may be designed with mechanisms that allow for manual actuation of incremental bolus doses. One form of manual actuation would require closing an electrical contact (e.g., one or two momentary switches) for an extended duration, after which a vibration or audible signal could confirm completion of drug delivery. The pre-programmed skin pump used in the exemplary embodiments of the present invention includes sufficient intelligence to perform sensing of insulin flow blockage, low insulin levels in the reservoir, and other fault conditions. The pre-programmed skin pump also preferably provides an alert to the user of each of these failure conditions. The pre-programmed skin pump performs similar functions as the "smart" skin pump, except for communication with the host device, thus greatly reducing the cost of providing medication therapy with such devices and enhancing the ease of use of such devices. The exemplary embodiment of themedical device 100 of the present invention preferably relates to a pre-programmable skin pump as described above.

Those of ordinary skill in the art will appreciate that in other embodiments of the present invention, themedical device 100 may also be provided as a fully programmable ("smart") or ("simple") package. Fully programmable packaging provides the user with the greatest accuracy and flexibility in controlling the rate of drug administration appropriate to the user's lifestyle, but at additional cost. Fully programmable "smart" skin pumps are typically used in conjunction with a Blood Glucose Monitor (BGM) or Continuous Glucose Monitor (CGM) and a host device (e.g., Personal Diabetes Monitor (PDM)) to provide personalized basal infusion rates through closed-loop control and sensing and single-dose infusions that can be actuated or adjusted at any time of day. The "smart" skin pump is preferably configured to communicate with a host device, for example, via a private network (as described in previously incorporated, co-pending U.S. application 12/458,807) or a wireless network. The "smart" skin pump may even communicate with the host device continuously or intermittently via a wired or other direct connection. A "simple" skin-contact pump may have little or no system intelligence and generally includes primarily a mechanical system for providing basic control of insulin infusion by presetting a basal rate or manually actuating a single injection. Each skin-contacting pump is particularly effective and desirable for certain types of users. The user's lifestyle, medical condition, economic condition, and ability to operate the medical device largely determine which type of skin pump package is suitable for the user. The specific features and functions of the exemplary embodiments of the present invention may be implemented next in each of the skin-mountable pump packages described above.

Additional embodiments, features, and specific functions of a skin Patch Pump to be used in accordance with the present invention may be found in commonly assigned U.S. Pat. No. 6,589,229 to Robert I Connelly et al, co-pending and commonly assigned U.S. patent Serial No. 12/458,807, and co-pending and commonly assigned U.S. patent application entitled "Flexible and Conformal Patch Pump" filed on even date herewith (attorney docket number P-8678(55581)), which is expressly incorporated herein by reference. One particular feature that may be provided in themedical device 100 as shown in fig. 1B relates to automatic or semi-automatic priming of the medical device prior to use. Adrug flow path 112 provided within the interior of themedical device 100 begins with thedrug reservoir 106 and terminates with an infusion needle inserted by the infusionneedle deployment mechanism 108. In this embodiment, a disc-shapedhydrophobic membrane 107 is placed in theflow channel 112 adjacent to the infusionneedle deployment mechanism 108. Thehydrophobic membrane 107 allows any air trapped within the void volume of theflow channel 112 to be expelled from the flow channel when thepumping mechanism 114 is initially activated. The fluid flow in theflow channel 112 will drive air from theflow channel 112 through thehydrophobic membrane 107, which prevents fluid flow from theflow channel 112 due to the particular membrane material and the pore size, distribution and density in the membrane. The use of ahydrophobic membrane 107 in the exemplary medical device is particularly effective because infusion requires little back pressure. The particular distribution, density, and size of the pores in the exemplary hydrophobic membrane may be selected based on the particular drug or fluid to be provided through the flow channel, as well as other performance requirements. The cessation of fluid flow in theflow channel 112 can be sensed and the user notified, allowing the user to complete the priming procedure and begin using the medical device.

A first exemplary embodiment of amedical device 100 constructed in accordance with the present invention is shown in fig. 3C. As noted above, one of the major challenges in extending the duration of use of conventional skin-contact pumps is maintaining the feasibility of the infusion site for an extended period of time. The infusion site may be defined as the site where the infusion needle enters the skin of the user. Maintaining a viable infusion site for more than 3 days is difficult because insulin can crystallize out in the infusion needle, thereby blocking the flow of insulin into the patient. In addition, the user's body may react adversely in response to foreign matter in the body. The tissue at the infusion site may become inflamed over time, resulting in increased resistance to infusion. If the infusion needle remains inserted into the tissue, cell growth may occur on the infusion needle and is likely to scar locally. The first exemplary embodiment of the present invention maintains the feasibility of the infusion site by advancing or retracting theinfusion needle 122 during the infusion cycle to vary the depth within the user's skin. By adjusting the depth of infusion during the infusion cycle, the risk of inflammation and scarring at the infusion site and its associated complications may be reduced or avoided.

Theinfusion needle 122 used in the exemplary embodiment of the present invention is preferably flexible to allow for extended use and user comfort, yet maintains a suitable breaking strength (column strength) that allows the infusion needle to be inserted into the user's body. As shown in fig. 3A, one exemplary embodiment preferably comprises astainless steel cannula 300 having a sharpened tip and alternatingslots 302 laser cut or chemically etched along the axis of the cannula. The alternatingslots 302 allow the cannula to flex and provide the rigidity or breaking strength necessary for insertion into the user's skin. Thestainless steel cannula 300 is preferably a single body with a sharpened tip at the distal end.Cannula 300 is preferably made of

Or

Thesleeve 304 is covered or coated, which provides a biocompatible outer fluid seal for allowing medication fluid to enter the user's body through the tip of the cannula. Exemplary embodiments of the invention

Additional disclosure of materials may be found in commonly assigned U.S. Pat. No. 5,226,899 to Min-Shiu Lee et alAnd 5,453,099 and U.S. patent No. 5,545,708 to Theo onwuaka et al, each of which is expressly incorporated herein by reference. Of course any suitable fluid impermeable material may be used to form the sheath or coating. Another exemplary embodiment of aflexible infusion needle 122 is shown in fig. 3B. The exemplary embodiment in fig. 3B preferably includes a sharpened stainlesssteel needle tip 306 attached to atorsion spring 308. Theneedle tip 306 allows for piercing the user's skin and is preferably welded to thetorsion spring 308, but may be attached using any suitable method. Thetorsion spring 308 provides similar benefits to the embodiment described in FIG. 3A and similarly includes

Or

Thesleeve 304 serves to seal the fluid within the interior cavity of the torsion spring. One of ordinary skill in the art will appreciate that thetorsion spring 308 and thestainless steel sleeve 300 may be provided with any suitable cross-section, and may alternatively include a rectangular cross-section to maximize the inner diameter. In addition, the tip of the infusion needle shown in fig. 3A and 3B need not include an opening for the flow of medication into the user's body. It may be desirable to implement an infusion needle having a closed end with a side port located near the tip for allowing the flow of medication into the body of the user.

Theinfusion needle 122 used in other exemplary embodiments may alternatively comprise a flexible cannula having a hardened tip that is optionally hardened relative to the cannula shaft for entry into the skin of the user, a flexible cannula inserted by means of a rigid insertion needle, or any other suitable device. The infusionneedle deployment mechanism 108 shown in fig. 1A may include a manual or automatic mechanism for inserting theinfusion needle 122 into the skin of the user or withdrawing the infusion needle. Additionally, theneedle deployment mechanism 108 may be manually or automatically actuated to insert the infusion needle into the skin of the user. Thecontroller 116 may actuate theneedle deployment mechanism 108 automatically after initialization of the medical device or based on some other programmed or sensed condition. Further, automatic deployment may be achieved via appropriate commands received from a BGM, PDM, or host device.

As shown in fig. 3C, theneedle deployment mechanism 108 includes adriver 118 for actuating insertion and retraction of aninfusion needle 122. An exemplary mechanism suitable for use with thedriver 118 of the present invention provides a motor electronically controlled by thecontroller 116 to drive theinfusion needle 122 in the insertion and withdrawal directions by rotating the threaded rod in a clockwise or counterclockwise motion, wherein the infusion needle moves axially along the threaded rod via a reciprocating threaded structure or sleeve. Alternative embodiments implement shape memory alloys and/or piezoelectric actuators that contract when an electrical charge is applied. Thecontroller 116 may apply a variable voltage to the shape memory alloy or piezoelectric actuator to achieve a desired distance of movement in the insertion or withdrawal direction to drive theinfusion needle 122. Other embodiments ofdrivers 118 suitable for use with the present invention may include a plurality of mechanically or electronically actuated latches and/or springs for effecting movement of the infusion needle in the insertion and withdrawal directions, as available to those of ordinary skill in the art. Thedriver 118 is preferably electronically controlled by thecontroller 116, however in certain embodiments thedriver 118 may be controlled by at least one of a thumb wheel and a mechanical dial or by actuating a button, sliding latch, or lever. Thedriver 118 used in the present invention is not limited to the above embodiment. One of ordinary skill in the art will recognize that any known mechanism capable of inserting and withdrawing a needle into a user may be suitable for use with embodiments of the present invention, such as those disclosed in U.S. patent No. 6,391,005 to Lum et al and U.S. patent publication No. 2004/0010207 to j.

In the exemplary embodiment of the invention shown in fig. 3D and 3E, theinfusion needle 122 is manually or automatically inserted into the skin of the user to a desired depth, e.g., 4mm, using any suitable method discussed above. Themedical device 100 then begins the infusion or injection of the medication to the user. After a predetermined period of time (e.g., 1 or 2 days) has elapsed, thecontroller 116 instructs thedriver 118 to advance theinfusion needle 122 further to a second depth, e.g., 5 mm. By providing a second infusion depth, theinfusion needle 122 may effectively infuse the drug into potentially non-inflamed tissue, thus extending the duration of use of the infusion site. The above operations may be repeated as desired or needed. Thus, after the second predetermined period of time has elapsed, thecontroller 116 further instructs thedriver 118 to advance theinfusion needle 122 to the third infusion depth. In another exemplary embodiment, thedriver 118 initially inserts theinfusion needle 122 to a depth of 5mm and after a predetermined period of time has elapsed, thecontroller 116 instructs thedriver 118 to withdraw theinfusion needle 122 to a second, shallower infusion depth. One of ordinary skill in the art will recognize that any of the above embodiments may be combined in the present invention. For example, thecontroller 116 may variably control the infusion depth by instructing thedriver 118 to insert theinfusion needle 122 to a desired depth, withdraw the needle after a first time period, and then drive the needle to the initial infusion depth or an alternate infusion depth after a second time period. Thedriver 118 may be configured to effect any number of changes in infusion depth. Alternatively, thedriver 118 may be configured to provide only a single depth change, which may be easily performed using purely mechanical structures that may be used in a simple skin-contact pump.

In another exemplary embodiment, as seen in fig. 3C, after initial insertion of theinfusion needle 122 and initiation of drug infusion, thedriver 118 may be controlled to fully or approximately fully retract theinfusion needle 122 from the infusion site for a predetermined period of time. In one embodiment, thedriver 118 may be actuated while the user is asleep to retract theinfusion needle 122 from the user for 8 hours, and then reinsert or drive theinfusion needle 122 to a desired depth while the user is awake. This embodiment will not only increase the feasibility of the infusion site by reducing the risk of inflammation of the infusion site, but it may also reduce the scarring of the patient's tissue.

Each of fig. 3C-3E shows thedriver 108 driving theinfusion needle 122 in a direction perpendicular to the skin of the user. In other embodiments, it is preferred that the infusion needle be angularly variably insertable and retractable into and out of the user's body. By inserting theinfusion needle 122 into the user at an angle, the infusion needle penetrates a greater amount of skin without penetrating to a greater depth. In view of the above embodiments, this may allow for an increased distance of infusion depth, thus providing a more increased duration of infusion site feasibility and improved user comfort.

Themedical device 100 used in the above embodiments may also include aflow sensor 120, as shown in FIG. 2, for detecting the flow rate of the medicament provided by thepump mechanism 114. Theflow sensor 120 can provide closed-loop flow control to thepump mechanism 114 to achieve and maintain a desired flow rate. Additionally, theflow sensor 120 may also have the ability to detect whether theinfusion needle 122 is occluded or whether the infusion site is blocking the desired drug infusion rate. In an exemplary embodiment, when it is detected by theflow sensor 120 that the infusion site may be occluded, thecontroller 116 preferably instructs thedriver 118 to withdraw or advance theinfusion needle 122 to a second infusion depth. Theflow sensor 120 may then detect whether the desired flow rate is achieved at the new infusion depth before potentially alerting the user. This exemplary embodiment may extend the duration of use of themedical device 100 by attempting a new infusion depth that may have the ability to provide a desired drug infusion rate without having to alert the user to replace themedical device 100.

Another exemplary embodiment of amedical device 100 for use in the present invention is shown in fig. 4 and 5. Themedical device 100 in fig. 4 preferably includes a first infusionneedle deployment mechanism 108a and a second infusionneedle deployment mechanism 108 b. The infusionneedle deployment mechanisms 108a and 108b may be separately actuated and are preferably (but not necessarily) located at opposite ends of themedical device 100. The infusionneedle deployment mechanisms 108a and 108b may be implemented in any of the embodiments described above with respect to the infusionneedle deployment mechanism 108 shown in fig. 3C. Themedical device 100 in this embodiment also preferably comprises at least oneflow sensor 120a or 120b for detecting and potentially alerting the user that the flow of drug through the respective infusion needle is blocked. In one exemplary embodiment, the infusionneedle deployment mechanism 108a is initially actuated manually or automatically to insert theinfusion needle 122 into the user to a desired depth. It is not required in this embodiment, although may be preferred, that theneedle mechanisms 108a and 108b be configured to variably advance and withdraw theinfusion needle 122 into the user as shown in fig. 3C-3E. After actuating theneedle deployment mechanism 108a to insert theinfusion needle 122 into the user, theflow sensor 120a preferably detects whether the flow of medication to the user is blocked. If it is determined that the drug flow is blocked, thecontroller 116 may preferably alert the user and instruct the user to manually actuate the infusionneedle deployment mechanism 108 b. Alternatively, thecontroller 116 may automatically actuate theneedle deployment mechanism 108 b. After actuating theneedle deployment mechanism 108b, thecontroller 116 preferably instructs thepump mechanism 114a to stop the flow of drug through theinfusion needle 122 of theneedle deployment mechanism 108b and to begin the flow of drug to the second infusion site provided by theneedle deployment mechanism 108 b.

In the above embodiments, variable withdrawal/insertion of theinfusion needle 122 may not be necessary because of the use of the twoneedle deployment mechanisms 108a and 108 b. Any suitable (mechanically or automatically actuated) needle deployment mechanism may be utilized in this embodiment. Simple, manually actuated, single usedeployment needle mechanisms 108a and 108B may be utilized in this embodiment, such as the needle mechanisms shown in fig. 6A and 6B utilizing snap discs or torsion springs. Fig. 6C and 6D illustrate another embodiment for the present invention that is particularly suited for theinfusion needle 122 shown in fig. 3A and 3B. As shown in fig. 6C, theinfusion needle 122 is attached to theneedle carriage 602. Theneedle carriage 602 is held in the withdrawn, ready position byretention latch members 604 which prevent movement of theneedle carriage 602 in the direction of insertion. The infusion needle deployment may be manually or automatically actuated to displace theretention latch element 604 from the occluded position. When theretention latch 604 is actuated, thecompression spring 606 drives theneedle carriage 602 in the insertion direction, as shown in figure 6D. After insertion of theinfusion needle 122 into the user, distal movement of theneedle sled 602 is prevented by a chassis or housing containing the needle deployment mechanism.

Fig. 6E and 6F illustrate another deployment mechanism for an infusion needle in a medical device according to an embodiment of the present invention. Rather than being triggered as in the previously described mechanisms, the needle deployment may be user controlled. That is, thecarriage 602 is biased in the retracted position by thecompression spring 606. Fig. 6E shows the device in a withdrawn position such that theinfusion needle 122 does not extend from the chassis. Thesled 602 includes a user accessiblemanual actuator 607. When the user moves the manual actuator in the direction of arrow 'a' with sufficient force to overcome the spring bias,sled 602 moves in the direction of arrow 'a' along withinfusion needle 122. Thecarriage 602 also includes finger latches 608 that mate withretention surfaces 609 on retention latches 610. As thecarriage 602 moves in the direction of arrow 'a', interference between thefinger latch 608 and theretention surface 609 causes theretention latch 610 to displace in the direction of arrow 'B'. The finger latches 608 and the retention surfaces 609 are shaped such that as the finger latches move past eachretention surface 609, thecarriage 602 is prevented from moving rearward in the retraction direction. As the carriage moves in the direction of arrow 'a', the infusion needle protrudes from the chassis and enters the skin surface of the user.Cantilever retention latch 610 may flex downward in the direction of arrow 'B' to releaseshuttle 602 and withdraw the infusion needle. One of ordinary skill in the art will appreciate that any suitable arrangement for releasing thecarriage 602 by flexing theretention latch 610 downward may be utilized. Such an arrangement may include manual movement by a user via a device provided on an outer surface of the chassis or automatic electronic release via an appropriate command on the PDM.

Fig. 6G and 6H illustrate the needle deployment mechanism of fig. 6C described above with aguide sleeve 123 for guiding theflexible infusion needle 122 into the user at a desired insertion angle. In addition, theguide sleeve 123 provides additional integrity to theflexible needle 122, preventing kinking or other undesirable deflection during deployment. It will be appreciated from fig. 6G and 6H that theguide sleeve 123 can be configured within a medical device to allow deployment in various orientations relative to the movement of theneedle sled 602. Thus, the use of theguide sleeve 123 in the exemplary embodiment allows for theinfusion needle 122 to be deployed into the skin while minimizing the effect of the needle deployment mechanism on the overall profile of the medical device by allowing the sled to move parallel to the skin.

As shown in fig. 4 and 5, themedical device 100 may include twoseparate pump mechanisms 114a and 114b to control the infusion to the user at the infusion sites provided by theneedle deployment mechanisms 108a and 108b, respectively. Alternatively, one of ordinary skill in the art will appreciate that asingle pump mechanism 114 may be provided to pump the drug to the user at each of the energized infusion sites. ThePump mechanism 114 may preferably be a piezoelectric diaphragm or a thermal bubble micropump as described in the previously incorporated co-pending U.S. patent application entitled "Flexible and Conformal Patch Pump" and any other suitable and well known Pump mechanism. One of ordinary skill in the art will recognize that thecontroller 116 may drive theneedle deployment mechanism 108a to insert or withdraw theinfusion needle 122 to the second infusion depth prior to alerting the user or automatically activating theneedle mechanism 108b, as described in the previous embodiments. In this exemplary embodiment, theinfusion needle mechanism 108b provides redundant infusion needles to allow therapy to continue at the second infusion site if flow to the first infusion site is blocked. One of ordinary skill in the art will also appreciate that theneedle deployment mechanism 108b may also be actuated in other circumstances, such as after a predetermined period of use at the first infusion site or in the event that the first infusion site becomes irritated or inflamed.

Additional features to be used in any of the above embodiments provide a route for heparinizing theinfusion needle 122. Heparinization of theinfusion needle 122 may be performed prior to initial insertion into the skin of the user or during variable insertion and retraction movements. Heparinization may be performed by coating theinfusion needle 122 with heparin by any method available to one of ordinary skill in the art. Heparinized infusion needles may facilitate protection of an infusion site by preventing blood clotting at the infusion site, which may block or otherwise complicate the infusion site. The drug heparin is one of the family of anticoagulants. Those skilled in the art will appreciate that similar drugs may be substituted for those which provide the same benefits without departing from the scope and spirit of this embodiment of the invention.

By providing protection to the infusion site by thesingle needle mechanism 108, by thesecond needle mechanism 108b, or a combination thereof, themedical device 100 is able to prolong the medication of the user compared to other available skin-contact pumps in the art. The modifications and enhancements necessary to provide extended functionality do not significantly increase the complexity of themedical device 100 and may be provided with simple, cost-effective components. While the unit cost of a singlemedical device 100 may increase slightly, the extended duration of use provided by the additional components necessarily reduces the daily cost of providing medication to the user through themedical device 100 and necessarily reduces waste.

As described in any of the exemplary embodiments above, the only challenge introduced by providing amedical device 100 capable of prolonged medication therapy for a user is to supply a sufficient volume of medication to the user during prolonged use of the medical device. Fig. 1, 4 and 5 show a preferred embodiment of areservoir 106 for providing a containing or storing supply of medicament.

The exemplary embodiment of themedical device 100 utilizing a singleinfusion needle mechanism 108 preferably includes asingle reservoir 106 as shown in fig. 1A. In a first embodiment, thereservoir 106 can contain a volume of drug that provides an adequate supply for an extended duration of use (e.g., 5-7 days). In this embodiment, thereservoir 106 may be provided as a pre-filled reservoir packaged in themedical device 100. Thereservoir 106 is preferably integrated with the skin-contact pump and does not require additional steps to transfer or engage the drug supply to themedical device 100. Thereservoir 106 may be provided as a rigid or flexible structure and is preferably constructed of a material such as

Materials of the type (thermoplastic olefin polymers of amorphous structure), COC (cyclic olefin copolymers), COP (cyclic olefin polymers) or CCP (crystal clear polymers) which are materials registered by Becton, Dickinson and Company and listed by the U.S. food and drug administration as DMF No. 16368. Any other known material for containing a drug may also be used in the present invention.

In another embodiment, as shown in fig. 7a, thereservoir 106 may comprise a refillable and/or refillable reservoir contained in themedical device 100. In this embodiment, the user may transfer the drug into thereservoir 106 through a fillingport 110 or septum preferably provided on the outer surface of themedical device 100. Conventional skin-patch pump kits typically include a syringe to transfer the drug from the vial into the reservoir. Alternatively, exemplary embodiments of the present invention provide apre-filled syringe 200 or pre-filled syringe containing a specific amount of drug suitable for the capacity of thereservoir 106 or customized according to the needs of the user. The pre-filled syringe and syringe may be included as part of a skin-mountable pump kit or as part of the packaging of the pre-filled syringe. Such embodiments necessarily reduce the complexity of using themedical device 100 and may also reduce the daily cost of therapies using such devices.

As shown in fig. 7b, another exemplary embodiment includes apre-filled reservoir assembly 700 or cartridge that is separate from themedical device 100. In this embodiment, the user may engage thepre-filled reservoir assembly 700 into themedical device 100, and this action may connect the pre-filled reservoir to the pump mechanism of themedical device 100. The capacity of the refillable/refillable reservoir 106 orprefilled reservoir assembly 700 described in the above embodiments may be determined by the configuration of themedical device 100 and the desired use of the particular user thereof. Since the reservoirs in these embodiments are refillable or replaceable, their capacity need not be sufficient to supply the drug during the entire duration of use of themedical device 100. However, it is preferred that thereservoir 106 has sufficient capacity such that it may only need to be refilled or replaced once during the duration of use of themedical device 100.

Fig. 4 and 5 illustrate an exemplary embodiment of thereservoir 106 provided in amedical device 100 including first and second infusionneedle deployment mechanisms 108a and 108 b.Reservoir 106 in fig. 4 may be implemented as in the embodiments provided above to supply bothneedle deployment mechanisms 108a and 108b with medicament. However, due to the increased number of components caused by the second infusionneedle deployment mechanism 108b, in order to save space, it is preferred that thereservoir 106 in fig. 4 contains a reduced volume and is refillable/replaceable during the duration of use of themedical device 100 as described above. The embodiment shown in fig. 5 includes tworeservoirs 106a and 106 b. In this embodiment, thereservoir 106a is provided to strictly supply the drug to theneedle mechanism 108a and thereservoir 106b is provided for supplying the drug to theneedle mechanism 108 b. Thereservoirs 106a and 106b are preferably prefilled, but may also be fillable/refillable or insertable/replaceable as described above.

The above embodiments reduce the daily cost of infusion delivery by extending the duration of use of wearable skin-worn pumps, which are typically discarded entirely after their use. In the above embodiments, themedical device 100 includes system components that can be safely reused. Thus, completely discarding the medical device results in unnecessary waste of usable, relatively expensive components. The daily cost of infusion delivery of such skin patches may be even further reduced by providing, in the above exemplary embodiments, medical devices that reuse relatively expensive components. Only those components that can be safely reused are preferably contained in the reusable portion of the medical device, while any non-safe or single-use components are preferably contained in the disposable portion.

As shown in fig. 8A, one exemplary embodiment of the present invention provides a partially reusable and partially disposablemedical device 100 according to any of the above exemplary embodiments. In one exemplary embodiment, themedical device 100 is designed such that only "sterile" or "used" components are replaced after each duration of use, as described in previously incorporated U.S. Pat. No. 6,589,229 to Robert I Connelly et al. For example, components that should be replaced after each use include: aninfusion needle 122, adrug reservoir 106, an adhesive for attaching themedical device 100 to a user, and an optional battery orpower source 109. In some embodiments, the disposable housing may also include aflow sensor 120 according to the exemplary embodiments described above to detect any blockage in the flow of drug to the user or the flow at the infusion site. These components are preferably enclosed in a two-piece sealed housing having exposed interfaces for theneedle deployment mechanism 108, thepump mechanism 114, andelectrical contacts 111 for electrically connecting theflow sensor 120 andoptional battery 109 to thecontroller 116. Thedrug reservoir 106 may be implemented as described in any of the exemplary embodiments above. If thereservoir 106 is fillable/refillable, afill port 110 or septum is preferably provided on the disposable housing.

In an exemplary embodiment, thecontroller 116,pump mechanism 114, andneedle deployment mechanism 108 are preferably housed within a separatereusable structure 130 that is similarly designed to thedisposable portion 132. Thedisposable portion 132 preferably latches with thereusable portion 130, thus automatically engaging thecontroller 116,pump mechanism 114, andneedle deployment mechanism 108 with theoptional battery 109 andflow sensor 120,drug reservoir 106, andinfusion needle 122, respectively. It should be understood by one of ordinary skill in the art that any of the above exemplary embodiments of themedical device 100 may provide both a reusable housing portion and a disposable housing portion. To ensure that thedisposable portion 132 of themedical device 100 is not used for more than a predetermined duration, in one exemplary embodiment of the invention, thecontroller 116 may be allowed to alert the user that the disposable portion should be replaced. Thecontroller 116 may also be allowed to disable thedisposable portion 132 after a certain number of warnings. Reusable components may include a needle deployment mechanism, electronic circuitry or system intelligence of the device, a fluid metering device or pump, and any housing components necessary for guiding, aligning, engaging or latching and unlocking the disposable portion. A rechargeable power source or other energy harvesting component may also be included inreusable portion 130, if desired. The reusable portion may also be configured with the necessary components to communicate with any other smart device using a private network or other communication technology, as disclosed in previously incorporated U.S. patent application serial No. 12/458,807. The information that may be communicated includes any system diagnostic information as well as a stored history of the user's infusion rate and schedule information. The particular components contained in the reusable and disposable housings depend on the preferred application of themedical device 100 and are not limited by the embodiments described above. One of ordinary skill in the art will appreciate that any combination of components and features may be provided as desired by a user.

In a preferred embodiment,reusable portion 130 is configured and constructed to be reused withdisposable portion 132 for a duration of two years or more. During this time, theelectrical interconnection 111 between the reusable and disposable portions is susceptible to failure. Typical electrical connections are fragile and may not withstand the type or lifetime for which the medical device is intended. An exemplary embodiment of the present invention enables the above-described use without thiselectrical connection 111 and allows thereusable portion 130 to communicate with thedisposable portion 132 using a Private Area Network (PAN) as discussed above. The cost of providing a PAN transceiver in thedisposable portion 132 is negligible, especially at the compromise of providing greater durability and extended use of the medical device assembly as compared to providing it.

Thereusable portion 130 of themedical device 100 accounts for 60% -70% of the overall device cost. Apportioning the cost over a predetermined period of time (e.g., 360 days or more) will substantially reduce the daily cost of drug infusion therapy to the cost of the disposable portion of the device. By further extending the duration of use of thedisposable portion 132 of the device according to the above embodiment, the daily cost is further reduced.

Fig. 2 and 9 also show another exemplary embodiment of amedical device 100 incorporating anoptional sensing unit 124 provided according to the above exemplary embodiment allowed by the extended duration of use. For diabetes care, the medical industry is moving towards closed loop systems for insulin infusion. An ideal system, typically referred to as an "artificial pancreas", includes a continuous glucose monitor to provide "real-time" or "near real-time" feedback for accurate insulin infusion control. Continuous glucose monitoring may be implemented within asensing unit 124 that includes asensor 126 for providing data regarding a user's blood glucose level.

Fig. 2 depicts thesensing unit 124 as being included in themedical device 100. Although this is a preferred embodiment, one of ordinary skill in the art will appreciate that thesensing unit 124 may be provided independently of themedical device 100. Thesensor 126 may be embodied as any known sensing or sampling technique. For example, some known sensing techniques utilize electrochemical, colorimetric, optical/spectroscopic, or other energy-based detection methods to determine the user's blood glucose level. In addition, there are two categories of well-known sampling techniques that can also be implemented, namely non-invasive and invasive. One exemplary embodiment of the present invention preferably utilizes a colorimetric or electrochemical sensor for sensing Glucose Binding Protein (GBP), such as a glucose oxidase (GOx) sensor described in U.S. patent No. 7,310,544 to Brister et al, and an analytical sensor disclosed in U.S. patent publication No. 2005/0245799 to Brauker et al, both assigned to dexcncom and expressly incorporated herein by reference. The implantable GOx described therein has been shown to provide a usage duration of up to seven days. Thus, heretofore, there has been a paradox in effectively implementing such sensing techniques in a conventional wearable skin-proximity pump due to the shorter duration of use of the skin-proximity pump compared to the sensor. The exemplary embodiments discussed above provide an extended usemedical device 100 that can match the performance of leading continuous glucose monitoring technologies.

As shown in fig. 9, sensingunit 124 preferably includessensor 126, discussed above, andsensor deployment mechanism 128. Thedeployment mechanism 128 may be manually or automatically actuated and may be embodied in any of the systems described above for the infusionneedle deployment mechanism 108. It should of course be understood that automatic deployment may be achieved via appropriate commands received from a BGM, PDM or host device. Theneedle deployment mechanism 108 discussed above, as well as the embodiments described in the previously incorporated U.S. patent application entitled "Flexible and Conformal Patch Pump" can be readily modified to provide for insertion of thesensor 126. For example, thesensor 126 may be provided at the end of a drive needle or pushrod, similar in construction to an infusion needle used to insert thesensor 126 into the skin of a user. Additionally, thesensor 126 may be positioned within the user's body by means of an insertion sleeve that is withdrawn once the sensor is placed at a desired depth within the user's body. Thesensor deployment mechanism 128 preferably provides a single insertion and retraction motion for inserting and retracting thesensor 126. Asensor deployment mechanism 128 may also optionally be provided to variably insert and withdraw thesensor 126, similar to that described above with respect to the exemplary embodiment of the infusionneedle deployment mechanism 108. Inflammation at the sensor insertion site or other physical reaction to foreign objects may prevent thesensor 126 from providing very accurate sensing information. Thus, by adjusting the insertion depth of thesensor 126, thesensing unit 124 may provide more accurate sensing information, resulting in greater accuracy of the infusion rate and improved user comfort. In one exemplary embodiment, thesensor deployment mechanism 128 is located at an opposite end of theinfusion needle mechanism 108. In another embodiment, thesensor 126 is co-located with theinfusion needle 122. Thus, in this embodiment, the sensor deployment mechanism and the infusionneedle deployment mechanism 108 may be embodied in the same structure.

Fig. 10A and 10B illustrate a system for providing continuous glucose monitoring and infusion rate control in an exemplary embodiment of the invention. Thecontroller 116 receives as input data from theflow sensor 120 and thesensor 126 and controls thepumping mechanism 114 accordingly to provide a desired infusion rate. A closed loop infusion control system in accordance with one embodiment of the present invention is described in U.S. patent No. 6,558,351 to Steil et al, assigned to Medtronic MiniMed, inc. The method described therein involves a closed-loop infusion control system in which a glucose sensor provides an input signal to a controller that in turn utilizes a proportional/derivative (PD) component that replicates a first phase insulin response and an integral (I) component that provides a second phase insulin response. PID controllers are well known in the art and provide a universal control loop feedback mechanism using three independent parameters, proportional, integral and derivative. The scaling parameter determines the reaction to instantaneous error in the system. The integral parameter determines the response from the sum of recent errors in the system, while the derivative parameter controls the response based on changes in the system error rate. The PID controller then determines the appropriate response based on a weighted sum of these parameters. While the PID controller discussed above may effectively control the rate of insulin infusion, each of the PID parameters is not required in the exemplary embodiment of the invention.

FIG. 10B shows a proportional-integral (PI) or proportional-derivative (PD) controller for use in an exemplary embodiment of the invention. Since the rate of change of the basal infusion is typically very small, PI and PD controllers effectively control insulin infusion. The PI and PD controllers may also provide adequate control for medical devices used to treat type II diabetes because the infusion rates in treating type II diabetes need not be instantaneously varied to significantly different levels. Exemplary embodiments of themedical device 100 may provide amotorized pump mechanism 114, such as a micro-motor or linear actuator with integral gear reduction, which may be effectively controlled using a PI or PD controller since the infusion rate need not be momentarily varied to significantly different levels. Additionally, because the maximum error or overshoot can be one step or ring increment, a step control motor in which the internal rotor and stator are designed to allow incremental rotation of the shaft or lead screw and a ring counter that senses the number of revolutions or partial revolutions of the shaft are two possible control options for thepump mechanism 114. Such high resolution linear actuators and motors with integral gear reduction are well known in the art and are available, such as those provided by Haydon Switch and Instrument and MicroMo Electronics. However, such systems sized for application in small, unobtrusive wearable medical devices are typically very expensive, as in the exemplary embodiments of the present invention. Thus, the cost for such controls is currently prohibitive for use in common, disposable, wearable medical devices. A large number of users prefer or need to provide control and accuracy in such embodiments. Accordingly, there is a need to provide continuous glucose monitoring with theabove pump mechanism 114 in a practical and user-affordable package.

As discussed above with respect to FIG. 8A, an exemplary embodiment of the present invention may incorporate thepump mechanism 114 described directly above in thereusable portion 130 of themedical device 100, which may last several years. The highprecision pump mechanism 114 described above is capable of performing well suited reuse in reusable embodiments. Thus, the cost of providing adedicated pump mechanism 114, as well as other relatively expensive system components, may be amortized over the lifetime of themedical device 100.

The exemplary embodiment of themedical device 100 preferably further comprises thesensing unit 124 for continuous glucose monitoring discussed above. In this embodiment, the reusable housing further includes asensor deployment mechanism 128, and the disposable housing contains thesensor 126. In one exemplary embodiment,electrical contacts 111 on the disposable portion will preferably connectsensor 126 tocontroller unit 116 for providing continuous glucose monitoring. Alternatively, as similarly discussed above, PAN communication techniques may be used to provide communication between thesensors 126 and thecontroller unit 116, and thus electrical contact may not be necessary. Since thesensor 126 can be embedded in the user for up to 7 days as described above, there is no unnecessary waste of components or cost in locating the sensor within the reusable portion of the extended usemedical device 100 in an exemplary embodiment of the invention.

As sensor technology continues to evolve, thesensor 126 may be able to provide a longer duration of use. Thus, as shown in FIG. 8B, an exemplary embodiment of the present invention provides an additional seconddisposable part 134 that is separate from thedisposable part 132 that houses the disposable insulin infusion component, as discussed in connection with FIG. 8A. In this embodiment, the second disposable portion may contain asensor 126, asensor deployment mechanism 128 for insertion of the sensor, and anoptional battery 109b, as shown. It is preferred that the second disposable part be located at the opposite end of the infusion needle mechanism from the firstdisposable part 132 to ensure that the sensor is deployed into viable tissue. The seconddisposable portion 134 is provided for allowing a longer duration of use of thesensor 126 so that the firstdisposable portion 132 containing components having shorter durations of use can be discarded without unnecessarily shortening the span of use of the morepermanent sensor 126. It is preferred thatreusable portion 130 and seconddisposable portion 134 remain in contact with the user while firstdisposable portion 132 is attached to the reusable portion. As described above, seconddisposable portion 134 may communicate withreusable portion 130 via a direct connection or may carry PAN communication components for communicating withreusable portion 130 or other external devices.

In fig. 8B, the firstdisposable portion 132 is shown with only a single needle deployment mechanism, however it may be preferred to provide a second needle deployment mechanism at a corner or end opposite the disposable portion, as described with respect to fig. 4 and 5, for increasing the duration of use of the firstdisposable portion 132. It is preferred that the second needle deployment mechanism is provided at an angle or end opposite the first deployment mechanism to provide a new viable infusion site at a distance from the first infusion site, thereby reducing the potential risk of irritation or inflammation at the first infusion site. Additionally, in another embodiment shown in fig. 8C-8F, each disposable portion 132a-d achieves a viable infusion site by positioning the corresponding needle deployment mechanism at a distance from the preceding needle deployment mechanism. Whilereusable portion 130 and seconddisposable portion 134 remain attached to the user, first disposable portions 132a-d are repeatedly attached toreusable portion 130 at a disposable housing engagement site. In a first example of attaching the disposable portion 132a shown in FIG. 8C, theneedle deployment mechanism 108 is disposed within one of the corners of the disposable portion 132 a. In fig. 8C, theneedle deployment mechanism 108 is disposed in the lower left corner. When the short term components of disposable portion 132a are used, a new, replacement, firstdisposable portion 132b is attached toreusable portion 130. Indisposable part 132b, the needle deployment mechanism is positioned at the other corner ofdisposable part 132 b. As shown in fig. 8D, theneedle deployment mechanism 108 is disposed in the upper left corner of thedisposable portion 132 b. Placement of each needle deployment mechanism in the disposable portions 132a-132d enables infusion sites that are between 0.5 to 2.5 inches apart from each other and preferably about 1.25 to 1.75 inches. The order of use of each disposable portion 132a-132d may be determined by the user so long as the needle deployment mechanism of the disposable portion implements a new infusion site. Disposable portions 132a-132d preferably include a "key"feature 135 that requires a particular orientation to attach one of the disposable portions toreusable portion 130. Thus, the key feature will prevent the user from attaching the disposable portion to the reusable portion in an orientation in which the infusion site is to be reused.

The features of the exemplary medical device discussed above are provided for extending the duration of use of the wearable medical device. Common wearable medical devices are attached to the skin of the user with an adhesive layer that covers substantially the entire surface area of the housing portion (attached to the user) or is typically provided as a perimeter profile of the medical device. However, the general configuration of the adhesive layer may not be suitable for the extended use medical device provided in the above exemplary embodiment. That is, common bonding techniques provide little freedom of movement at the interface between the medical device and the soft, stretchable skin surface of the user. During extended use, conventional adhesive layers may not withstand slight stretching of the user's skin at the interface or may prove too uncomfortable for the user. Thus, theadhesive layer 150 shown in fig. 11A provides a pattern (e.g., a zigzag pattern) for allowing increased freedom of movement at the interface between the user's skin and the exemplary medical device. Such patterns reduce the user's attention to the physical sensation attendant to the adhesive surface and prolong normal use by allowing minute movements to occur on the skin surface during normal physical activity. It is preferred that the adhesive layer comprises a continuous pattern, thereby also providing a seal against water ingress. The adhesive layer is also preferably formed or fabricated from a flexible material that allows for slight stretching as shown in fig. 11A and 11B. It is preferred that the freedom of movement provided by the adhesive 150 be slight and should not result in undesired movement at the infusion site. However, in one embodiment, an additional less flexible adhesive ring orperimeter 152 serving as an anchor may be provided at theinfusion site 153 for preventing any undesired movement at the site, as shown in fig. 11B and 11C. In such embodiments, it is preferred that theadhesive ring 152 have a higher tack and reduced flexibility relative to theadhesive layer 150 or 154. Thereby, the flexibility and comfort of the adhesive layer along the circumference of the medical device can be maintained without compromising theinfusion site 153. Additional embodiments may also include anadhesive layer 150 or 154 having not only a lower viscosity but also an increased thickness, or an elastomeric or foam layer sandwiched between the adhesive layer and the medical device for providing additional freedom of movement. The patterns shown in fig. 11A and 11B are not limiting. Any such zigzag or curvilinear pattern of adhesive may be provided to enhance the extended wearability of themedical device 100 according to an exemplary embodiment. Further, as shown in fig. 11C, theadhesive layer 154 that is contoured along the perimeter of the medical device may also achieve the desired flexibility discussed above by utilizing reduced tackiness, increased flexibility, and/or thickness of the adhesive layer, as well as implementing an elastomeric or foam layer sandwiched between the adhesive layer and the medical device. In this embodiment, theadhesive layer 154 need not be in a zig-zag, curvilinear or other non-uniform continuous pattern.

In any of the exemplary embodiments described above, themedical device 100 may also be used in conjunction with a programmabledrug delivery device 400, such as a programmable insulin injection pen, as shown in fig. 12A-12B. In a preferred embodiment, the wearable medical device is configured to provide only a preset, pre-programmable or programmable base infusion rate, while the programmabledrug delivery device 400 is provided for infusing the necessary bolus dose. While certain embodiments of wearable medical devices discussed above are capable of providing a single dose, some users may prefer to use familiar pen injection devices and feel more comfortable, such as the pen injection device shown in fig. 12A. Additionally, for some users, medication provided by the insulin injection pen device alone may be an effective treatment. Conventional mechanical insulin pen-type injection devices typically require user interaction to accurately set the desired injection dose. Conventional mechanical pens often include small dose scales that may be difficult to see or accurately set. Thus, in an exemplary embodiment of the present invention, the programmable insulininjection pen device 400 will eliminate the potential risk of dosage errors resulting from the user's inability to properly operate the device.

In one embodiment of the present invention, when not in use, thedrug delivery device 400 preferably remains attached to a Personal Diabetes Manager (PDM)500, a Blood Glucose Monitor (BGM), or other device for calculating bolus doses. When the user instructs the PDM500 to calculate a bolus dose requirement, the PDM calculates the dose from the basal rate infusion history, the user's blood glucose level determined from standard test strips or communicated by body function sensors, or information about the meal the user will consume, and automatically programs the dose into thedrug delivery device 400 without requiring any further calculation, setting or adjustment by the user. PDM500 may preferably include a sensing mechanism or other system for determining blood glucose levels to be used to calculate the desired bolus dose for the user. This exemplary embodiment of the present invention reduces the number of steps necessary for infusion and reduces dosage errors caused by the user's inability to properly operate a conventional mechanical insulin injection pen.

In an exemplary embodiment, thedrug delivery device 400 preferably includes areplaceable insulin cartridge 402 and may be cylindrical, similar to commonly available insulin injection pens. The dose mechanization typically located in the upper part of a common insulin injection pen is preferably replaced by a flexible circuit surrounding the inner diameter of the barrel. The flex circuit serves as acontroller 404 for controlling a drug metering mechanism (e.g., a micro-pump 406 or motor) to deliver a programmed dose to a user. Therechargeable battery 408 may be located on the centerline of the cylinder inside the flex circuit. Thereplaceable insulin cartridge 402 would be located in the lower portion of the injection pen and the micro-pump 406 is preferably located between theinsulin cartridge 402 and theinfusion needle 410. Themicropump 406 may be implemented by any of the techniques discussed above and provided in the previously incorporated co-pending application entitled "Flexible and Conformal Patch Pump" (attorney docket number P-8678 (55581)). In some embodiments, the micro-pump 406 may be replaced by a motor disposed proximal to theinsulin cartridge 402 to drive a movable stop to force fluid directly into theinfusion needle 410. In this embodiment, the linear actuator may be placed inside the flex circuit in line with the insulin bottle. The linear actuator applies a force to drive a plunger or stopper disposed in the vial, resulting in a single dose equal to the displacement volume of the plunger movement. Very small linear actuators are available and can be used advantageously for this purpose. One example is manufactured by New Scale Technologies

A linear actuator. Injection penPreferably separate for replacement of the insulin cartridge and, when assembled, provide an electrical connection to the micro-pump 406 or motor. Therechargeable battery 408 in thedelivery device 400 may be charged each time thedrug delivery device 400 is attached to the PDM500, and the infusion history or blood glucose history stored in the injection pen may be automatically uploaded to thePDM 500.

An exemplary embodiment of the present invention may provide thedrug delivery device 400 with the low cost components necessary for communication via a private area network, as described in the previously incorporated co-pending U.S. patent application serial No. 12/458,807. This embodiment allows continuous communication between thedrug delivery device 400 and the PDM500 or "smart" wearable medical device as disclosed in the above exemplary embodiments. The "smart" medical device or PDM may automatically program thedrug delivery device 400 whenever a bolus dose is calculated, as long as both are physically connected to the user's body. A "smart" wearable medical device that incorporates or otherwise communicates with a biosensor may also be able to provide a single dose requirement to thedrug delivery device 400 that will be automatically programmed by the device based on the user's blood glucose level. In addition, thedrug delivery device 400 may automatically update the PDM or "smart" medical device via the private network each time a bolus dose is administered to the user. The above embodiments provide a low cost, intelligent device that is capable of further enhancing the functionality of the exemplary wearable medical device disclosed above in embodiments that are easy to use and familiar to many users who need insulin therapy.

While the present invention has been shown and described with reference to certain exemplary embodiments, it is not to be restricted by the exemplary embodiments but only by the appended claims and their equivalents. It is to be appreciated that those skilled in the art can change or modify the exemplary embodiments without departing from the scope and spirit of the present invention.

Claims (14)

1. A programmable drug delivery device for administering a drug treatment to a user, the programmable drug delivery device comprising:

a housing comprising a programmable controller, a drug cartridge, an infusion needle and a mechanism for metering a calculated bolus dose of a drug to be administered to a user, wherein the controller is programmed by a host device which calculates a bolus dose of a drug to be administered to a user through the infusion needle and programs the controller to set the dose to be administered to a user.

2. The programmable drug delivery device of claim 1, wherein the programmable drug delivery device comprises a programmable insulin injection pen.

3. The programmable drug delivery device of claim 1, wherein the host device is one of a personal diabetes monitor, a blood glucose monitor, a single dose calculator, and a wearable drug infusion device.

4. The programmable drug delivery device of claim 1, wherein the host apparatus calculates a bolus dose in accordance with at least one factor selected from the group consisting of: test strip results, body function sensor signals, basal rate infusion history, and meal information.

5. The programmable drug delivery device of claim 1, wherein the housing further comprises electrical contacts for direct communication with the host apparatus.

6. A programmable drug delivery device according to claim 5, wherein the programmable controller is programmed by the host device when in direct communication therewith.

7. The programmable drug delivery device of claim 5, wherein the housing further comprises a rechargeable battery that is recharged when the programmable drug delivery device is in contact with the host apparatus.

8. A programmable drug delivery device according to claim 1, wherein the programmable delivery device and the host device communicate via a private area network that transmits signals across the body of a user.

9. A programmable drug delivery device as in claim 1, wherein the mechanism for metering the calculated bolus dose of drug administered to the user comprises a micro-pump disposed between the infusion needle and the drug cartridge.

10. A programmable drug delivery device as in claim 1, wherein the mechanism for metering the calculated bolus dose of drug administered to a user comprises a linear actuator disposed at a proximal end of the drug cartridge, the linear actuator displacing fluid in the drug cartridge.

11. A wearable medical device for administering a drug treatment to a user, the medical device comprising:

a unitary housing, said unitary housing comprising: a reservoir for containing a supply of a drug in fluid communication with an infusion cannula for delivering the drug to a user;

pump mechanism means for administering delivery of the drug from the reservoir to a user through the infusion cannula; and

a pre-programmed controller that controls the pump mechanism to provide a pre-programmed drug delivery profile to a user.

12. The medical device of claim 11, wherein the controller is pre-programmed by a manufacturer or healthcare provider of the medical device.

13. The medical device of claim 11, wherein the controller is preprogrammed to provide a specific drug infusion rate according to an electronic timer or time of day.

14. The medical device of claim 11, wherein the controller is preprogrammed to provide multiple daily infusions of a dose of medication to a user.

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